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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017808

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NDA 017808 describes MIACALCIN, which is a drug marketed by Mylan Ireland Ltd and is included in two NDAs. It is available from three suppliers. Additional details are available on the MIACALCIN profile page.

The generic ingredient in MIACALCIN is calcitonin salmon. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.

Summary for NDA: 017808

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 017808

Ingredient-typeCalcitonin

Suppliers and Packaging for NDA: 017808

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIACALCIN
calcitonin salmon
INJECTABLE;INJECTION 017808 NDA Sebela Pharmaceuticals Inc. 54766-149 54766-149-23 2 mL in 1 VIAL, MULTI-DOSE (54766-149-23)
MIACALCIN
calcitonin salmon
INJECTABLE;INJECTION 017808 NDA Mylan Institutional LLC 67457-675 67457-675-02 1 VIAL, MULTI-DOSE in 1 CARTON (67457-675-02) > 2 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100 IU/ML
Approval Date:Jul 3, 1986TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200 IU/ML
Approval Date:Mar 29, 1991TE:RLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Julphar
Fish and Richardson
McKinsey
Express Scripts
Deloitte
Teva
Cantor Fitzgerald
Cipla
Chinese Patent Office
Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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